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FDA issues final mobile medical app guidance

from By Pamela Lewis Dolan

The U.S. Food and Drug Administration recently issued its final guidance on mobile health apps, ending a two-year wait for developers. The FDA, which issued a draft guidance in July 2011, said it intends to exercise its enforcement discretion and not regulate apps except for those that present a risk to patients if they do not work as intended. While some industry groups were happy the FDA made good on its promise to release the document before the end of fiscal year 2013, others say the FDA should have waited a little longer. more

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